Heart Failure With Reduced Ejection FractionPhase 4ASTRO-CHFNCT05072054
Comparison of Effects of Atorvastatin Versus Rosuvastatin on Cardiac Function in Heart Failure Patients
A Phase 4 study testing Atorvastatin Oral Tablet and Rosuvastatin Oral Tablet in people with Heart Failure With Reduced Ejection Fraction, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Statins have a protective effect in patients with established heart failure because of their lipid-lowering and pleiotropic effects. There is no randomized controlled trial comparing lipophilic versus hydrophilic statins in these patients (head to head comparison). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Atorvastatin Oral Tablet and Rosuvastatin Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 16 Oct 2019to 31 Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either gender,18-65 years of age
- Left ventricular ejection fraction <40% as assessed by 2D echocardiography
- NYHA class II-III
- CHF patients currently optimized on standard treatment for at least 1 month before enrolment and on an OPD basis treatment
- Ready to give written informed consent
- Willing to comply with the study protocol
Who cannot join
- Known hypersensitivity to statins
- NYHA class IV patient
- Serum creatinine >3 mg/dl
- Significant liver disease: SGOT/SGPT >3 times the upper limit of normal (ULN) or >2.5 times the ULN in symptomatic patients
- Patient on an enzyme inducer or inhibitor currently
- Any malignancy or patient on chemotherapeutic agents
Show all 10Show fewer
- Pregnant or lactating females
- Patients who have participated in another trial within the past 3 months
- Patient with uncontrolled diabetes mellitus (HbA1c >7 g%)/ uncontrolled hypertension (BP >140/90 mmHg despite in ≥3 antihypertensive drugs)
- Patient with HIV/ HBV / HCV infection
Trial locations and contacts
1 site in 1 country.
Rachna Rohilla, MD contact
India1 site, 1 recruiting
- Recruiting
Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh, 160012
Ashish kakkar, MD, DM, 91-172-2755297, drashishkakkar@gmail.com
Rachna Rohilla, MD, rachna.rohilla20@gmail.com
About this study
Official title: Comparison of Effects of Atorvastatin Versus Rosuvastatin Treatment on Cardiac Function and Inflammation in Patients With Chronic Heart Failure With Reduced Ejection Fraction: A Randomised, Double Blind Clinical Study
Statins have a protective effect in patients with established heart failure because of their lipid-lowering and pleiotropic effects. There is no randomized controlled trial comparing lipophilic versus hydrophilic statins in these patients (head to head comparison). The best evidence so far is from a meta-analysis in which the authors did an adjusted indirect comparison between lipophilic statins and rosuvastatin and found that lipophilic statins were associated with significantly lower incidence of all-cause mortality, cardiovascular mortality, and hospitalization for worsening heart failure compared to rosuvastatin (hydrophilic statin) among patients with heart failure. So, the investigators plan to conduct a randomized controlled trial comparing the effects of atorvastatin and rosuvastatin on cardiac function in patients with heart failure with reduced ejection fraction.
Read the detailed description
HMG CoA reductase inhibitors or Statins have been widely used for primary prevention and secondary prevention of atherosclerotic cardiovascular disease. Also, the protective effect of statins has been observed in patients with established heart failure because of their lipid-lowering and pleiotropic effects.
Various randomized and non-randomized clinical trials have evaluated statins like Atorvastatin, Rosuvastatin, Simvastatin, Pitavastatin and reported improved clinical outcomes in patients with heart failure with reduced ejection fraction as well as heart failure with preserved ejection fraction. Similar benefits on improved cardiac function, reduced inflammation, and improved mortality have been seen in small randomized controlled trials (RCTs) with Atorvastatin. The two large RCTs - Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA) and Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza cardiac (GISSI-HF) - which compared Rosuvastatin versus placebo, failed to show statistically significant benefits in mortality outcomes in heart failure patients compared to placebo, although CORONA trial did show a significant reduction in hospital admissions but not on mortality.
However, these two large trials only compared one statin i.e rosuvastatin versus placebo; which is a hydrophilic statin. Statin is not a uniform class of drugs. They differ in their pleiotropic effects based on lipophilic nature. There is evidence that lipophilic statins enter cells via passive diffusion and are widely distributed to various tissues including cardiac tissues where it exerts pleiotropic actions whereas uptake of hydrophilic statins is via carrier-mediated mechanisms and is restricted to the liver, thus reduced the capacity of non-lipid effects on extra-hepatic tissues.
Currently, there is no RCT comparing lipophilic statin versus hydrophilic statin (head to head comparison). The best evidence so far is from a meta-analysis which is an adjusted indirect comparison between lipophilic statins and rosuvastatin. They found that lipophilic statins were associated with a significantly lower incidence of all-cause mortality, cardiovascular mortality, and hospitalization for worsening heart failure compared to rosuvastatin (hydrophilic statin) among patients with heart failure. So, the investigators plan to conduct a randomized controlled trial comparing the effects of atorvastatin and rosuvastatin on cardiac function and inflammation in patients with heart failure with reduced ejection fraction.
- Being tested
- Atorvastatin Oral Tablet, Rosuvastatin Oral Tablet
- Keywords
- Atorvastatin, Rosuvastatin, Heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin Oral TabletDrug
Atorvastatin 40 mg
Rosuvastatin Oral TabletDrug
Rosuvastatin 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin arm | Experimental | Tablet Atorvastatin 40mg once daily at bed-time given for 6 months Receives: Drug: Atorvastatin Oral Tablet |
| Rosuvastatin arm | Active comparator | Tablet Rosuvastatin 20mg once daily at bed-time given for 6 months Receives: Drug: Rosuvastatin Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effect of atorvastatin and rosuvastatin on LVEF
Change from baseline in Left ventricular ejection fraction (LVEF) measured by 2D Echocardiography after atorvastatin or rosuvastatin treatment
Measured: Measurements at enrolment (baseline), 3 month and 6 months
To compare the effect of atorvastatin and rosuvastatin on NT-ProBNP
Change from baseline in NT-ProBNP (cardiac marker) after atorvastatin or rosuvastatin treatment.
Measured: Measurements at enrolment (baseline), 3 months and 6 months
Secondary outcomes (6)
To compare the effect of atorvastatin and rosuvastatin on IL-6
Change from baseline in IL-6 levels after atorvastatin or rosuvastatin treatment
Measured: Measurements at enrolment (baseline) and 6 months
To compare the effect of atorvastatin and rosuvastatin on hsCRP
Change from baseline in hsCRP levels after atorvastatin or rosuvastatin treatment.
Measured: Measurements at enrolment (baseline), 3 month and 6 months
To compare the effect of atorvastatin and rosuvastatin on Minnesota living with heart failure questionnaire (MLHFQ)
Change from baseline in Minnesota living with heart failure questionnaire (MLHFQ) after atorvastatin or rosuvastatin treatment. MLHFQ consists of 21 questions and each question has a score from 0 to 5.
The total score ranges from 0 to 105, with higher scores indicating greater impairment in health related quality of life.
Measured: Measurements at enrolment (baseline), 3 month and 6 months
To compare the effect of atorvastatin and rosuvastatin on 6-minute walk test (6MWT)
Change from baseline in 6-minute walk test (6MWT) after atorvastatin or rosuvastatin treatment.
Measured: Measurements at enrolment (baseline), 3 month and 6 months
Compare incidence of hospitalization for worsening of heart failure at 6 months in atorvastatin and rosuvastatin group
Incidence of hospitalization due to worsening of heart failure in 6 months in both groups
Measured: Analysis at 6 months
Compare incidence of adverse events and major adverse events including all-cause mortality, non-fatal MI, stroke in atorvastatin and rosuvastatin group.
Incidence of adverse events including serious adverse events in 6 months in both groups
Measured: Analysis at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start16 Oct 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, Ashish Kakkar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Ashish K Kakkar, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072054
- Sponsor's protocol ID
- PGIMER-CV-2019
- Acronym
- ASTRO-CHF
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Atorvastatin Versus Rosuvastatin Treatment on Cardiac Function and Inflammation in Patients With Chronic Heart Failure With Reduced Ejection Fraction: A Randomised, Double Blind Clinical Study
- ClinicalTrials.gov ID
- NCT05072054
- Acronym / sponsor ID
- ASTRO-CHF / PGIMER-CV-2019
- Keywords
- Atorvastatin, Rosuvastatin, Heart failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Statins have a protective effect in patients with established heart failure because of their lipid-lowering and pleiotropic effects. There is no randomized controlled trial comparing lipophilic versus hydrophilic statins in these patients (head to head comparison). The best evidence so far is from a meta-analysis in which the authors did an adjusted indirect comparison between lipophilic statins and rosuvastatin and found that lipophilic statins were associated with significantly lower incidence of all-cause mortality, cardiovascular mortality, and hospitalization for worsening heart failure compared to rosuvastatin (hydrophilic statin) among patients with heart failure. So, the investigators plan to conduct a randomized controlled trial comparing the effects of atorvastatin and rosuvastatin on cardiac function in patients with heart failure with reduced ejection fraction.
Detailed description
HMG CoA reductase inhibitors or Statins have been widely used for primary prevention and secondary prevention of atherosclerotic cardiovascular disease. Also, the protective effect of statins has been observed in patients with established heart failure because of their lipid-lowering and pleiotropic effects.
Various randomized and non-randomized clinical trials have evaluated statins like Atorvastatin, Rosuvastatin, Simvastatin, Pitavastatin and reported improved clinical outcomes in patients with heart failure with reduced ejection fraction as well as heart failure with preserved ejection fraction. Similar benefits on improved cardiac function, reduced inflammation, and improved mortality have been seen in small randomized controlled trials (RCTs) with Atorvastatin. The two large RCTs - Controlled Rosuvastatin Multinational Study in Heart Failure (CORONA) and Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza cardiac (GISSI-HF) - which compared Rosuvastatin versus placebo, failed to show statistically significant benefits in mortality outcomes in heart failure patients compared to placebo, although CORONA trial did show a significant reduction in hospital admissions but not on mortality.
However, these two large trials only compared one statin i.e rosuvastatin versus placebo; which is a hydrophilic statin. Statin is not a uniform class of drugs. They differ in their pleiotropic effects based on lipophilic nature. There is evidence that lipophilic statins enter cells via passive diffusion and are widely distributed to various tissues including cardiac tissues where it exerts pleiotropic actions whereas uptake of hydrophilic statins is via carrier-mediated mechanisms and is restricted to the liver, thus reduced the capacity of non-lipid effects on extra-hepatic tissues.
Currently, there is no RCT comparing lipophilic statin versus hydrophilic statin (head to head comparison). The best evidence so far is from a meta-analysis which is an adjusted indirect comparison between lipophilic statins and rosuvastatin. They found that lipophilic statins were associated with a significantly lower incidence of all-cause mortality, cardiovascular mortality, and hospitalization for worsening heart failure compared to rosuvastatin (hydrophilic statin) among patients with heart failure. So, the investigators plan to conduct a randomized controlled trial comparing the effects of atorvastatin and rosuvastatin on cardiac function and inflammation in patients with heart failure with reduced ejection fraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind clinical study
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin arm | Experimental | Drug: Atorvastatin Oral TabletTablet Atorvastatin 40mg once daily at bed-time given for 6 months |
| Rosuvastatin arm | Active comparator | Drug: Rosuvastatin Oral TabletTablet Rosuvastatin 20mg once daily at bed-time given for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Either gender,18-65 years of age
- Left ventricular ejection fraction <40% as assessed by 2D echocardiography
- NYHA class II-III
- CHF patients currently optimized on standard treatment for at least 1 month before enrolment and on an OPD basis treatment
- Ready to give written informed consent
Key exclusion criteria (10 listed)
- Known hypersensitivity to statins
- NYHA class IV patient
- Serum creatinine >3 mg/dl
- Significant liver disease: SGOT/SGPT >3 times the upper limit of normal (ULN) or >2.5 times the ULN in symptomatic patients
- Patient on an enzyme inducer or inhibitor currently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin Oral TabletAtorvastatin 40 mg | Drug | Atorvastatin arm |
| Rosuvastatin Oral TabletRosuvastatin 20 mg | Drug | Rosuvastatin arm |
Primary outcome
To compare the effect of atorvastatin and rosuvastatin on LVEF
Time frame: Measurements at enrolment (baseline), 3 month and 6 months
Change from baseline in Left ventricular ejection fraction (LVEF) measured by 2D Echocardiography after atorvastatin or rosuvastatin treatment
To compare the effect of atorvastatin and rosuvastatin on NT-ProBNP
Time frame: Measurements at enrolment (baseline), 3 months and 6 months
Change from baseline in NT-ProBNP (cardiac marker) after atorvastatin or rosuvastatin treatment.
6 secondary outcomes
To compare the effect of atorvastatin and rosuvastatin on IL-6
Time frame: Measurements at enrolment (baseline) and 6 months
To compare the effect of atorvastatin and rosuvastatin on hsCRP
Time frame: Measurements at enrolment (baseline), 3 month and 6 months
To compare the effect of atorvastatin and rosuvastatin on Minnesota living with heart failure questionnaire (MLHFQ)
Time frame: Measurements at enrolment (baseline), 3 month and 6 months
To compare the effect of atorvastatin and rosuvastatin on 6-minute walk test (6MWT)
Time frame: Measurements at enrolment (baseline), 3 month and 6 months
Compare incidence of hospitalization for worsening of heart failure at 6 months in atorvastatin and rosuvastatin group
Time frame: Analysis at 6 months
Compare incidence of adverse events and major adverse events including all-cause mortality, non-fatal MI, stroke in atorvastatin and rosuvastatin group.
Time frame: Analysis at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachna Rohilla, MD contact
Ashish K Kakkar principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin Oral Tablet and Rosuvastatin Oral Tablet in people with Heart Failure With Reduced Ejection Fraction, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashish Kakkar, MD, DM (91-172-2755297, drashishkakkar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the effect of atorvastatin and rosuvastatin on LVEF (time frame: Measurements at enrolment (baseline), 3 month and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.